Evaluating the Effects of Improving Nutritional Intake on Wound Healing in Patients With Diabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in dietary intake of nutrients
研究概览
简要总结
The overall aim of this study was to assess the effects of nutritional supplementation and education on the healing of foot ulcers in diabetic patients. The hypothesis was that improving dietary intake can promote wound healing by improving nutritional status, blood flow, and decreasing inflammatory biomarkers while increasing anti-inflammatory factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or non-pregnant, non-lactating female ages 50 ± 20 years, diagnosis of diabetes mellitus, undergoing pharmacological treatment for glycemic control, with at least one foot with one ulcer of grade 1A based on University of Texas classification -
排除标准
- •Subjects were excluded from the study if they had HbA1c concentrations > 12%, bioengineered tissue use within four weeks prior to initial screening, a history of radiation treatment to the ulcer site, known immunosuppression, active malignancy, chronic kidney disease, liver failure/cirrhosis, heart failure and/or myocardial infarction in the past three months, use of warfarin, alcohol abuse, or any mental or physiological condition that may interfere with nutrition education and nutritional supplement intake.-
结局指标
主要结局
Change in dietary intake of nutrients
时间窗: 12 weeks
Mean change from baseline in dietary intake of energy(kcal), protein(g), vitamin C(mg), vitamin E(IU), vitamin A(IU), Zinc(mg), Copper(mg), and Manganese(mg) at weeks 4, 8, and 12.
Change in inflammatory biomarkers
时间窗: 12 weeks
Mean change from baseline in c-reactive protein(ng/ml), interleukin 6(pg/ml), interleukin 10(pg/ml), and tristetraprolin(pg/ml) at weeks 4, 8, and 12
Change in lean body mass and body fat
时间窗: 12 weeks
Mean change from baseline in lean body mass(lb) and body fat(lb) at weeks 4, 8, and 12
Improvement in wound healing rate(mm^2/week)
时间窗: 12 weeks
Mean change from baseline in wound area at weeks 4,8, and 12 using the following formula Wound Healing rate= (current area-baseline area)/time (number of weeks)
次要结局
- Change in Ankle Brachial Index(ABI)(12 weeks)
- Length of time that a wound achieves complete wound closure(12 weeks)
- Change in basal metabolic rate(12 weeks)
研究者
Raedeh Basiri
Principal Investigator
Florida State University